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Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).

R

Rambam Health Care Campus

Status

Completed

Conditions

Ventilator Lung; Newborn

Treatments

Device: nasal intermittent positive pressure ventilation (NIPPV).

Study type

Interventional

Funder types

Other

Identifiers

NCT04836689
RMB-0490-20

Details and patient eligibility

About

Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate.

Full description

This will be a prospective, crossover observational study that will be performed at Rambam NICU.

Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition.

NIPPV rate will start high/low, changed to low/high and switched back to starting rate.

Enrollment

50 patients

Sex

All

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gestational age 240 to 336.
  • At least 6 hours of stabilized NIPPV settings, i.e. minor changes in settings (FiO2 ≤0.10, PIP≤ 2.0 cmH2O, RR≤ 5 brm).
  • At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
  • At least 6 hours from surfactant administration.
  • Parental consent

Exclusion criteria

  • If NIPPV set rate is 10 bpm and tcCO2 related pCO2 is<40mmHg.
  • If NIPPV set rate is 30 bpm and tcCO2 related pCO2 is>60mmHg.
  • Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

50 participants in 2 patient groups

30 breaths per minutes
Other group
Description:
Using NIPPV with rate of 30 for 1 hour. Measuring trans cutaneous CO2
Treatment:
Device: nasal intermittent positive pressure ventilation (NIPPV).
10 breaths per minute
Other group
Description:
Using NIPPV with rate of 10 for 1 hour. Measuring trans cutaneous CO2
Treatment:
Device: nasal intermittent positive pressure ventilation (NIPPV).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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